System and method of use for ligating and cutting tissue

ABSTRACT

The invention is directed to a medical device for endoscopically ligating and cutting a body vessel. The device may be percutaneously inserted into a patient to perform several possible procedures. The improvements to the device include a hinged jaw capable of grasping and crimping body vessels. An improved clip delivery system and an improved clip which ligate body vessels are also described. The instrument includes a rotating cutting member which provides more efficient body vessel cutting means. Furthermore, the entire system allows a simplified and more efficient method of operation.

This application is a divisional application Ser. No. 09/058,006, filedApr. 9, 1998, which has been issued on Jun. 5, 2001 (U.S. Pat. No.6,241,740).

BACKGROUND OF THE INVENTION

This invention generally relates to devices for performing endoscopicmedical procedures. More specifically, this invention relates to devicesfor ligating and cutting body vessels. When performing medicalprocedures it is often necessary to ligate, or block the flow of, bycrimping, a body vessel such as a vein or artery. It may also benecessary to cut the vessel. In endoscopic procedures the surgicaltreatment occurs at a distance, through a small incision in thepatient's skin. In these procedures cutting and ligating vesselsgenerally requires specialized instrumentation inserted through theincision. Even with such instrumentation these functions can bechallenging.

When grasping a vessel in preparation of other procedures it isimportant to obtain a secure grip on the vessel. It is also important toavoid dislodging the vessel from its normal position. Vessels which arenot securely grasped are difficult to ligate and cut. Vessels which aredislodged from their normal position may spring back or recede fromtheir new position once the procedure has been completed. Additionally,vessels which are dislodged may avulse, or damage connecting mainbranches, or in other words, moving a tributary may damage a saphenousvein. Loosely grasped vessels unduly complicate the medical procedure.Furthermore, after cutting a vessel in two or more places, a securelygrasped vessel can be “harvested” by withdrawing the instrument and thegrasped vessel.

Many current devices grasp body vessels by sliding over them in aneffort to trap them within the instrument. This procedure produces aninsecurely grasped vessel, due to the one-way trapping employed. Thisprocedure also presents an uncertainty as to whether the vessel isadequately trapped within the instrument. Furthermore, these devicestend to dislodge the vessel from its normal position in an effort totrap the vessel. This is especially so for minimally invasive deviceswhich are often very long. The normal movement of the operators hands ismultiplied by the length of the device, so distal tip manipulation isdifficult to control.

When ligating a vessel it is important to completely and securely cutoff the flow of the vessel. The clips used for ligation need to maintaina sufficient compression on the vessel to stop flow within the vesseland to remain secured on the vessel. Clips which leak or becomedislodged from the vessel unduly complicate the medical procedure.

Current devices use several different methods of ligating a body vessel.One method uses a closed clip construction of a particularconfiguration, which requires the clip to be mechanically bent open byan applicator to advance the clip over the body vessel. This requiresthe clip to be flexible enough so that bending the clip open will notpermanently deform the clip more than is necessary to apply the clip. Amore flexible clip will most likely be larger in size or have lowerretention force to the vessel it is applied to.

Another method uses an open clip construction, which requires the clipto be crimped after advancing the clip over the body vessel. Thisrequires the medical device to provide sufficient force to permanentlydeform the clip over the body vessel. As in the first method, thisrequires the clip to be formed of relatively flexible material.Regardless of the material used, the permanent deformation duringcrimping can compromise compression strength by reducing the springforces in the clip. Open clips take up more space and thus requirelarger delivery systems. Creating the great force necessary to closeclips tends to be quite complex when it must be done in a small,disposable delivery system. Closed clips require much less force toapply, are easier to apply (because the force is applied along thelength of the device and not perpendicular to it), and have tighterdimensional control in their applied state because they are closed in amanufacturing environment with clip forming machinery.

When cutting body vessels it is important to maintain a consistentcutting force so that the cut edges of the vessel are even andconsistent. Inconsistent or uneven edges may be difficult to laterre-attach or permanently close. Current devices use a scissoring methodwith a hinged lever-type action to cut a vessel. Such a method producesa cutting force which varies with the distance from the hinge point.Variations in cutting force varies the cutting efficiency and mayproduce uneven edges or an incomplete cut.

Since many different procedures exist which require endoscopic ligatingand cutting of vessels it is necessary that the device be capable ofvariable and multiple functions within a single procedure. Suchoperating flexibility has been difficult to achieve in a simple, easy touse device. The complexity of endoscopic surgery requires that theinstrumentation be easily manageable. A simple hand-held device with aminimum of control mechanisms is preferrable to more complex designs.

One of the great difficulties associated with minimally invasive surgeryis the time required to change out the surgical tools. Minimallyinvasive surgery is typically performed through a small number of“ports” that are often not near to the targeted surgical region. Thislimits the number of devices allowable and hinders the locating of thebusiness ends of the devices at the surgical region. Multi-functiondevices help in this regard.

What has been needed and heretofore unavailable is an endoscopicinstrument which is capable of efficiently ligating and cutting a bodyvessel and having sufficient operating flexibility to be used in variousprocedures. Furthermore, a ligating clip has been needed whichcompletely and reliably stops the flow through a body vessel duringsurgery. The present invention satisfies these needs.

SUMMARY OF THE INVENTION

The invention is directed to novel features in a medical device forcutting and ligating body vessels. The improvements include a hinged jawto grasp the vessel, an improved delivery system of an improved ligatingclip and a rotating cutter. The hinged jaw improves the efficiency ofgrasping the body vessel by not sliding over the vessel during insertionof the instrument, and then clamping down securely over the vessel. Animproved ligating clip is provided which does not lose compressionstrength due to overbending during the procedure. The ligating clipdelivery system is configured to store and deploy the improved clipswithout bending or crimping during the procedure. The rotating cutter isable to provide a more efficient cut by avoiding the deficiencies ofprevious cutters. The co-location of these features provides userflexibility and eliminates the time usually spent on changing out singlefunction tools.

The instrument's distal end, containing manipulating devices, ispercutaneously inserted into a patient, so that an operator can manuallycontrol the procedure by using the instrument's control devices locatedoutside the patient. The instrument's manipulating devices can then beadvanced over selected body vessels. The instrument, controlled by theoperator, then grasps the vessel using a hinged jaw. Once the vessel isgrasped, the operator, using the control devices, proceeds to ligate orcut the body vessel. The operator may perform either or both of thesefunctions in any order desired.

This instrument provides improved ligating of body vessels. Because theinstrument advances the clip over the vessel, rather than bending theclip open and then releasing the clip over the vessel, the clip can becomposed of very stiff material without compromising the compressionforce due to over bending. Both the instrument and the clip of thepresent invention include improvements which allow the clip simply to beadvanced over the vessel. This allows for smaller clips (open clips takemore space), which, in turn, allows for a smaller instrument, whichallows for a smaller percutaneous incision.

This instrument also provides improved cutting of body vessels. By usinga rotating cutter this invention avoids the variation in cutting forcetypical of other cutters. This consistency in cutting force leads tocleaner and more efficient cuts. Moreover, equipping the instrument withbi-directional cutting capabilities, versatility as well as the cuttingfunction itself are enhanced. Additionally, co-location of the cutterand ligator minimizes the amount of vessel tissue extending beyond theclip application site, which, in turn, thereby maximizes the length of avessel being harvested and eliminates the chance of inadvertentlycutting non-target tissue.

Other features and advantages of the invention will become apparent fromthe following detailed description, taken in conjunction with theaccompanying drawings, which illustrate, by way of example, the featuresof the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view depicting a medical instrument embodyingthe features of the invention.

FIG. 2 is a perspective view of the distal end of the medical instrumentof FIG. 1 depicting the manipulating assembly with the jaw in the openposition.

FIG. 3 is a perspective view depicting the manipulating assembly of FIG.2 with the jaw in the closed position.

FIG. 4 is a perspective view depicting the manipulating assembly of FIG.3 with the cutting member extended and rotated.

FIG. 5 is a perspective view of an alternative preferred embodiment ofthe applicator.

FIG. 6 is a perspective view of one embodiment of the manipulatingassembly, illustrating a hook for a acquiring vessels.

FIG. 7 is a partial cross-sectional side view depicting the manipulatingassembly of FIG. 2 with the jaw in the open position.

FIG. 8 is a partial cross-sectional side view of the manipulatingassembly of FIG. 3 with the jaw in the closed position.

FIG. 9 is a perspective view of one embodiment of the manipulatingassembly, illustrating flares positioned on the manipulating assembly.

FIG. 10 is a side view of one embodiment of the manipulating assembly,illustrating depth indicators configured on the manipulating assembly.

FIG. 11 is a partial cross-sectional view of the actuation assembly ofyet another preferred embodiment.

FIG. 12 is a side view of an alternative preferred embodiment of apushrod assembly.

FIG. 13 is an enlarged perspective view depicting a first embodiment ofa ligating clip.

FIG. 14 is an enlarged perspective view depicting a second embodiment ofa ligating clip.

FIG. 15 is an enlarged perspective view depicting a third embodiment ofa ligating clip.

FIG. 16 is an enlarged perspective view depicting a fourth embodiment ofa ligating clip.

FIG. 17 is an enlarged perspective view depicting a fifth embodiment ofa ligating clip.

FIG. 18 is an enlarged perspective view depicting a sixth embodiment ofa ligating clip.

FIG. 19 is an enlarged perspective view depicting an seventh embodimentof a ligating clip.

FIG. 20 is an enlarged perspective view depicting a eighth embodiment ofa ligating clip.

FIG. 21 is an enlarged partial view of a ligating clip, depicting theligating surfaces thereof.

FIG. 22 is a cross-sectional side view depicting the clip storage andloading features of the invention.

FIG. 23 is a partial cross-sectional view depicting the triggermechanism of another preferred embodiment.

FIG. 24 is a partial cross-sectional view of the feed mechanism ofanother preferred embodiment.

FIG. 25 is a partial cross-sectional view of the feed mechanism shown inFIG. 24, with the first pushrod moved proximally.

FIG. 26 is a partial cross-sectional view of the feed mechanism shown inFIG. 25, with the first pushrod moved distally.

FIG. 27 is a partial cross-sectional view of is an alternative preferredembodiment of the first pushrod.

FIG. 28 is a partial cross-sectional view of the pushrod shown in FIG.27 moved distally.

FIG. 29 is a partial cross-sectional view of an alternative embodimentof the pushrod shown in FIG. 28.

FIG. 30 is an elevational view depicting a first embodiment of thecutting member.

FIG. 31 is a side view depicting a second embodiment of the cuttingmember.

FIG. 32 is a side view depicting a third embodiment of the cuttingmember.

FIG. 33 is a side view depicting a fourth embodiment of the cuttingmember.

FIG. 34 is a perspective view depicting an alternative embodiment of themanipulating and cutting assembly with the jaws in an open position.

FIG. 35 is a perspective view of the device shown in FIG. 34, showingthe jaws in a closed position.

FIG. 36 is a perspective view of the device shown in FIG. 35, showingthe cutter being rotated.

FIG. 37 is a perspective view depicting the fixed jaw member embodyingfeatures of the invention.

FIG. 38 is a perspective view depicting another preferred embodiment ofthe jaw members.

FIG. 39 is a perspective view depicting a first embodiment of slots inthe cutting member and elongated shaft.

FIG. 40 is a perspective view depicting a second embodiment of slots inthe cutting member and elongated shaft.

FIG. 41 is a perspective view depicting a third embodiment of slots inthe cutting member and elongated shaft.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIGS. 1 through 4 illustrate a medical instrument embodying the featuresof this invention, which is designed to grasp, ligate, and possibly cuta body vessel. Generally the invention includes an actuating assembly 20at one end, an elongated shaft 22 extending distally away from theactuating assembly, and a manipulating assembly 24 at the distal end ofthe shaft. The actuating assembly is handled by the operator andincludes the devices which control the operation of the instrument. Thedistal end of the instrument, including the manipulating assembly andportions of the elongated shaft, can be percutaneously inserted into apatient. The manipulating assembly can then be positioned onto the bodyvessel being treated. The manipulating assembly can then be used tograsp, ligate, and possibly cut the body vessel.

Similar instruments, known in the art, are used to grasp, ligate and cutbody vessels. These devices often use grasping means which requiresliding the instrument over the vessel in order to trap the vessel. Thedevices ligate the vessel either by mechanically bending open a closedclip and then advancing the clip over the vessel and releasing the clip,or advancing an open clip over the vessel and crimping the clip onto thevessel. The cutting means of these devices use either lever-typescissors or a razor to cut the vessel. The improvements of the presentinvention include, grasping the vessel within the instrument's jaw 26,advancing an improved clip 28 over the vessel without bending orcrimping the clip, and a rotating cutting means.

This invention, as with similar instruments, is designed to be operatedmanually. Therefore, the actuating assembly 20 is equipped with a handle32 which can be used by the operator to position the instrument within apatient's body. The handle is attached to a barrel 34 which is disposedgenerally perpendicular to the handle, but can also be parallel or inline with the barrel (See FIG. 5). The actuating assembly is alsoequipped with at least one trigger 36 and at least one cutting knob,button or lever 38 which are adapted for manual operation of the devicesat the distal tip of the elongated shaft 22. The elongated shaft andmanipulating assembly 24 are sufficiently narrow, approximately 5 mm, tobe percutaneously inserted into the patient and advanced through thebody to a body vessel to be treated. Once the manipulating assembly isproperly positioned over a body vessel this invention is capable ofmultiple procedures.

FIGS. 2 and 3 illustrate the grasping procedure of the invention whichis accomplished using the jaw 26. The figures illustrate, by way ofexample, the jaw having a hinged jaw member 40 and a fixed jaw member 42both extending away from the distal tip of the shaft. The hinged jawmember is attached to a hinge 44 near the attachment between the fixedjaw member and the distal tip of the elongated shaft 22. The hinged jawmember has a grasping surface, 46 and the fixed jaw member has agrasping surface 48. These surfaces are designed to receive a bodyvessel and hold it securely. In a preferred embodiment at least one ofthe grasping surfaces includes a stop or arm 90 near the proximal end ofthe surface to aid in preventing the vessel being inserted too far intothe device. The upper jaw member and the lower jaw member may alsodefine a channel 70 between them. The channel defines an opening 71 atthe distal end of the jaw and continues proximally through the jaw.Grasping surfaces 46, 48 can have geometry (eg. teeth) or surfacetreatments (eg., sticky coating) for facilitating grasping. Moreover,either jaw may have a distal hook 35 to aid in acquiring the vessel (SeeFIG. 6).

The configuration depicted defines two positions for the jaw. In theopen position 54 the grasping surfaces 46, 48 of the hinged jaw member40 and the fixed jaw member 42 are spread apart. In this open positionthe jaw may be advanced over a body vessel 50. In the closed position 56the grasping surface of the hinged jaw member 46 and the graspingsurface of the fixed jaw member 48 are in contact or in close proximitywith each other. In this position, the jaw 26 firmly grasps the bodyvessel.

In the embodiment illustrated, the hinged jaw member 40 extendsproximally beyond the hinge 44 (See FIGS. 7 and 8). Either jaw membermay have flares or depth indicators 37 to assist the visualization ofthe vessel within the jaws (See FIGS. 9 and 10). The pushrod 58 isspring loaded so that the hinged jaw member can be in the open or closedposition 54 or 56. When a first pushrod 58 is advanced forward into theproximal end of the hinged member it actuates the hinge member into theclosed position 56 (See FIGS. 7 and 8). When a first pushrod 58 isadvanced backward away from the hinged member it actuates the hingemember into the open position 54. The first pushrod is housed within orcan be part of the elongated shaft 22 and extends proximally through theshaft to the actuating assembly 20. At the actuating assembly the firstpushrod is connected to the trigger 36 so that squeezing the triggeradvances the first pushrod and actuates the jaw into the closedposition. The trigger, or first pushrod, can be spring loaded so thatreleasing the trigger retracts the first pushrod and actuates the jawinto the open position.

In one preferred embodiment of the actuation assembly (See FIG. 11), thetrigger and jaws are in the reverse configuration where jaws are springloaded to the closed position and squeezing the trigger will open thejaws. When the trigger is released the jaws are pushed back to theclosed position by the spring force. This allows the user the ability tonot have to hold the jaws closed while a clip is being applied or thevessel is being cut.

As shown in FIG. 12, in one preferred embodiment, the first pushrod 58is an assembly embodying a proximal portion 59, a distal portion 65 anda spring 67 interspaced therebetween. The distal portion includes anangled surface 69 which engages that part of the jaw member whichextends proximally beyond the hinge 44, and by way of a wedging action,operates to close the jaws. By so configuring the assembly with spring67, the jaws can be closed with the specified force supplied by thespring. This limits the closing force so tissue inside the jaws does notget squeezed to the point of being damaged. Further, the wedging actionmakes it more difficult for the jaws to be pried open at the mouththereof by a spring clip that is being applied to a vessel that isbunching up or expanding in some manner within the jaws.

This invention will also be operable with embodiments not illustrated inthe figures. The jaw may be composed of two hinged members which operatein unison or otherwise. The hinged members may be actuated by similarmechanical or assisted mechanical means such as electric, hydraulic orpneumatic means. Instead of a trigger, the control device may beconfigured as a button, a switch or any equivalent device.

This invention is contemplated to ligate the body vessel using animproved clip 28. The clip can be configured in several ways asillustrated by FIGS. 13 through 21. Essentially the clip is a singlecomponent folded or twisted onto itself so that an upper member 60 and alower member 62 are formed. A compressive force is provided at thedistal end between these members as they are compressed together ie.folded over on each other. This configuration also defines a receivingend 63 of the clip and a closed end 61 of the clip.

The improvement of this clip is that during ligation the members 60, 62only open as wide as necessary to enclose the body vessel 50 to betreated. The members have lips 64 formed at the receiving end 63 of theclip by diverging the upper member 60 and lower member 62 away from eachother at their ends. These lips allow the clip to receive the vesselbetween the upper member and lower member and spread the members apartas the vessel passes through the clip. This improvement allows the clipto be spread over the vessel with a minimum of bending. Also thecompressive (spring load) forces between the members will never be lessthan their maximum potential because the members will never be bent openmore than is necessary to receive the vessel. While stiffer materialsprovide greater compressive forces, they are also more likely topermanently deform if the clip is bent open by the instrument for thepurpose of receiving a vessel. Therefore, with this improvement the clipcan be composed of as stiff a material as possible without compromisingthe compressive forces due to overbending.

In a preferred embodiment, as shown in FIG. 13, the clip 28 is formedfrom a narrow thin plate, flat wire or even square wire which is foldedonto itself leaving a compressive force between its two members 60 and62. The lips 64 are formed by bending the tips of the plate away fromeach other at the receiving end 63. Vessel retention structure may beconfigured on opposed faces which separate to increase stability of theclip on the vessel. In its relaxed state, the retention surfaces may bein contact under force or there may be a slight gap therebetween.

In one embodiment, shown in FIG. 14, the clip 28 is formed as a closedtubular member at the closed end 61 and narrows to two flat plates atthe receiving end 63. The lips 64 are formed by bending the plates awayfrom each other at their tips.

In another embodiment, shown in FIG. 15, the clip 28 is formed from aflat plate which is folded onto itself and then twisted. The twist addsreinforcement to the moment that supplies the compressive force betweenthe distal ends of the members 60 and 62. The lips 64 are formed bybending the tips of the plate away from each other at the receiving end63.

In a further embodiment, shown in FIG. 16, the clip 28 is formed from asingle wire twisted to form two ligating surfaces 66 similar to a paperclip with the bonding surfaces in the same horizontal plane. The mouth64 is formed by bending the wire segments away from each other at thereceiving end 63.

In yet another embodiment, shown in FIG. 17, the clip 28 is formed froma single wire folded onto itself to form the single ligating surface 66.The lips 64 are formed by bending the wire ends away from each other atthe receiving end 63. The wire is twisted near the closed end to helpprevent the body vessel 50 from advancing too far into the clip.

In another alternative embodiment, shown in FIG. 18 the clip 28 isformed from a narrow thin plate which is twisted onto itself forming aloop at the closed end 61. The lips 64 are formed by bending the tips ofthe plate away from each other at the receiving end 63.

A modification which can be applied to all of the configurations isillustrated in FIG. 19. By forming waves 68 in one or both of themembers 60 and 62, the clip 28 will form alternating areas of relativelyhigh and relatively low compression at the ligating surface 66. Therelatively high areas of compression will increase the grasping force onthe body vessel 50.

FIG. 20 illustrates a modification which can be applied to all of theconfigurations. By increasing the radius of curvature of the bends inthe clip 28 near the closed end 61 a stiffer material can be used so theclip will have a higher spring force, creating a higher compressionforce at the ligating surface 66, while allowing a sufficientflexibility near the receiving end 63.

Another modification, not illustrated, is to have a small gap betweenthe members 60, 62 as opposed to having them in contact when the clip 28is closed. This modification permits larger vessels to be ligatedwithout overbending the clip. The gap may also become narrower or widertoward the closed end 61 of the clip.

The ligating surfaces 66 of the clip members 60, 62 may also be modifiedto minimize slip across the surface. The surface may be notched,knurled, scaled or filed. Many patterns can be made into the bondingsurfaces. (See for example FIG. 21, which illustrates a surfaceembodying oriented chevron shaped recesses 79.)

The ligating surfaces 66 of the clip may be modified with various meansto further prevent slippage. Mechanical means such as interlocking teetheither lengthwise or cross wise may be employed. The clips may alsoinclude a shark tooth configuration, wherein the surface contains sharpridges with edges facing the closed end 61 of the clip. The surfaces mayalso be coated with non-slip substances, such as silicone rubber.

When the jaw 26 has grasped a body vessel 50 the instrument is inposition to ligate the vessel. The jaw also crimps the vessel into a lowprofile which facilitates the application of the clip 28. The clip isadvanced out of a channel 70 defined in the jaw and over the crimpedbody vessel.

FIG. 22 illustrates, by the way of example, the ligating function of theinvention. A clip 28 is disposed within the elongated shaft 22 adjacentthe jaw 26. A second pushrod 72, in-line with the clip, is used todistally advance the clip through the channel 70 defined in the fixedjaw member 42 and the hinged jaw member 40. The channel is configured sothat it is in-line with, and accessible by, the second pushrod and theclip only when the jaw is in the closed position 56. Furthermore, thecrimped body vessel is positioned by the jaw to be in-line with thereceiving end 63 of the clip. Therefore, advancing the second pushrodadvances the clip over the body vessel which spreads the members 60, 62of the clip until the body vessel is fully ligated.

The second pushrod 72 is housed within the elongated shaft 22 andextends proximally through the shaft. At the actuating assembly 20, thesecond pushrod is attached to a second trigger 73 so that squeezing thesecond trigger advances the second pushrod and advances the clip overthe body vessel 50. The second trigger and/or the second pushrod arespring loaded so that the second pushrod is retracted when the secondtrigger is released. In another preferred embodiment FIG. 23, the firstpushrod 58 and second pushrod 72 are coupled together to one trigger 73which both actuates the jaw and advances the clip. The assembly of thepushrods and trigger may be configured so that different positions ofthe trigger may define different functions being performed by thepushrods. This invention is also operable with embodiments notillustrated in the figures. The clip advancing function of the medicaldevice has been described as a simple mechanical device. Many morecomplex devices are able to perform this function as well. An electricdevice may advance the clips and pushrod using an electric motor.Pneumatic or hydraulic means may be utilized by forcing a fluid behindthe pushrod so that it extends like a piston. Furthermore, othermechanical means may be employed to advance the clips over the vessel.

This instrument may be configured to house and deploy several clipswithin a single procedure. FIG. 22 illustrates, by way of example, thefeatures associated with this improvement. A plurality of clips 74 maybe housed within a separate storage tube 76. The storage tube may be ofany configuration which facilitates the storage of multiple clips whileallowing for the deployment of clips as they are to be used. As anexample, the storage tube may be a tubular shaft, slightly larger indiameter than the clips, extending through the elongated shaft 22. Theproximal end of the storage tube contains an advancing spring 78 whichacts to force the plurality of clips distally. At the open distal end ofthe storage tube, a side ram 80 defines a staging area 82. The stagingarea may be configured to accept a single clip advancing distally fromthe storage tube due to the force of the advancing spring. The side ramincludes a loading spring 84 which acts to force the side ram, and theclip in the staging area, into position to be advanced by the secondpush rod 72.

When the second pushrod 72 is in a distally advanced position, itprevents the loading of the clip 28 in the staging area 82 by occupyingthe area to which the clip would be loaded. When the second pushrod isretracted, the distal end of second pushrod is proximal to the stagingarea and side ram 80. This allows the loading spring 84 to force theside ram, staging area, and clip to a position in-line and distal to thesecond pushrod. As the second pushrod is advanced distally with the sideram, staging area, and clip in-line with the second push rod, the sideram is configured to be forced back in-line with the storage tube 76,compressing the loading spring 84. Furthermore, the side ram isconfigured so that as it is forced back in-line with the storage tube,the clip 26 in the staging area is left in-line with the second pushrod.This leaves the staging area empty so that another clip is advanced intoit as it returns to a position in-line with the storage tube. The clipthat is in-line with the second pushrod is now ready to be advancedthrough the channel 70 and over the vessel 50.

The embodiments of these features may vary without affecting theoperability of the invention. The staging and loading of the clips maybe accomplished with similar mechanical and mechanical assisted means.As shown in FIGS. 24-26, for example, the feed mechanism can include aleaf spring 81 which cooperates with sideram 80 to accomplish loading aclip 28 for application upon a vessel. In this embodiment, when thefirst pushrod 58 is pulled proximately, the lead clip is pushed forwardby the force applied by advancing spring 78 and is guided sideways bysideram 80 into a position beyond and in line with the first pushrod 58.The longitudinal movement of the pushrod 58 is such that its distal endtravels a distance great enough to make room for a single clip 28 in thestaging area. The leaf spring 81 is stiff enough to maintain theadvanced clip within the interior of the distal portion of the device.As the first pushrod 58 is once again advanced forward, it engages theclip 28 in the staging area with a force which overcomes the restrainingforce of the leaf spring, thereby pushing the forward-most clip 28 outtoward the vessel to be ligated. The next clip in sequence is then in aposition to be advanced into the staging area and the process isrepeated.

Additionally, as shown in FIGS. 27 and 28, in one preferred embodimentthe first pushrod 58 is an assembly embodying a proximal portion 83, anactuator piston or distal portion 85, a spring 87 interspaced betweenthe proximal portion and distal portion, and a stop 89. Proximal portion83 includes a recess 91 configured in its terminal end within which thespring 87 is attached at one end and which is adapted to receive distalportion 85, to which the second end of the spring is attached. Such apushrod has the advantage of guaranteeing that the vessel is locatedcompletely inside the clip 28 as well as controlling the force, byselecting springs with desired forces, which advances the clip 28 overthe vessel. In operation, the pushrod assembly is advanced distallyuntil the proximal portion 85 engages the stop. At this point, the cliphas been advanced over the vessel. Where the vessel being ligated isvery small in diameter so that the force to apply a clip over it isrelatively small (ie., less than the force supplied by the spring), thenthe spring will advance the second portion of the pushrod and the clipfurther forward over the vessel. As shown in FIG. 29, the recess formedin the proximal portion of the pushrod can have a stepped configurationso that the spring does not have to be compressed to a solid height.

Furthermore, additional means for feeding a clip 28 may include electricmotors or hydraulic pumps. The staging and loading of the clips may alsobe performed manually by devices attached to the actuating assembly 20or elongated shaft 22. With such a manual means the clips could beloaded individually, by placing the clip into position to be advanced.

This invention may also be configured to cut the grasped body vessel 50,using an improved cutter. FIGS. 2 through 4 illustrate, by way ofexample, the features associated with this improvement. While the bodyvessel is grasped and crimped by the jaw 26, a cutting member 86 havingat least one cutting edge 88 (as shown in FIGS. 30-33) may be advancedover the jaw and body vessel if it is not already there (See FIGS. 34-36which shows the rotating cutter 86 configured on the fixed jaw). Thecutting member may then be rotated in either direction generally aboutthe axis of the elongated shaft. As the cutting member is rotated one ofthe sharpened edges will cross the body vessel and cut it.

In the embodiment illustrated the cutting member 86 is a distalextension on the elongated shaft 22. The cutting member has cuttingedges 88 along both sides. The fixed jaw member 42 has complementarycutting edges 90 (as shown in FIG. 37) along its sides, so that when theelongated shaft and cutting member are rotated the cutting edges of thecutting member and fixed jaw member cross each other in a scissoringaction. Significantly, bidirectional cutting eliminates the need torotate the distal end of the device to an appropriate position.

FIGS. 30-33 illustrate several possible configurations of the cuttingmember 86 and cutting edges 88. In one embodiment, as shown in FIG. 30,the cutting member and cutting edge have at least one angular bevel 92which further narrows the extension near the distal tip. Thisimprovement varies the angle of the cut during the cutting stroke.Another embodiment, as shown in FIG. 31, has serrations 94 in thecutting edges which increase the cutting efficiency and maintains thesharpness of the cutting edges. Another embodiment, as shown in FIG. 32,the cutting extension and cutting edges have the shape of an arcenclosing the area grasped by the jaw 26. This improvement captures thebody vessel 50 to be cut as the arc-shaped cutting edge of the cuttingmember sweeps across the complementary cutting edges 90. Anotherembodiment, as shown in FIG. 33, the cutting member has at least oneangular inward slant 96, which brings the distal tip of the cuttingmember closer to the cutting surface. This improvement increases thecutting force near the distal tip of the cutting member due to increasedcompression between the cutting edge and the complementary cutting edgeas the cutting member is forced to bend against the slant.

The fixed jaw member 42 can also be modified to increase cuttingefficiency. The fixed jaw member can increase in width near the distaltip as illustrated in FIG. 37. This has a similar effect as slanting thecutting member 86 inward near the distal tip shown in FIG. 33. Thecompression is increased between the cutting edge 88 and thecomplementary edge 90 as the extension is forced to bend away from theincreased width of the fixed jaw member. The ramps 52 near the proximalend of the fixed jaw member may also be edged to provide a lead-in edge98 to prevent the edges from binding each other when cutting action isinitiated. The edge on the cutting member may similarly have a lead-inedge 198 (FIG. 34) to replace or compliment the ramps 52. Anothermodification to jaw geometry 42 that can increase cutter scissoringaction is illustrated in FIG. 38. This modification can be made whilemaintaining jaw geometry similar to FIG. 37 or having a straightprofile. Angle #2 in FIG. 38 is increased by canting the surface, on topof and adjacent to edge 90, an angle #1. The increased angle #2 is anincreased angle between cutting edges 90 and 98 and can improve cutterscissoring action.

Most examples have shown the cutting member 86 cutting on thecomplementary edge 90 on the fixed jaw, but the cutting member 86 cancut on the complimentary edge 90 on the hinged jaw also (See FIGS.34-36). This is a more preferred method because no distal/proximaltranslation is required for 86 to stay clear of the hinged jaw in theopen position. Rotating 86 is the only movement required for cutting.

As illustrated in FIG. 39, there are modifications to the elongatedshaft 22 which improve the cutting efficiency. Slots in the elongatedshaft may be used to increase the flexibility of the elongated shaft,reducing the tendency of the cutting member 86 to bind on thecomplementary cutting edge 90. FIG. 39 depicts a single longitudinalslot 100 in the elongated shaft opposite the cutting member. The slotextends from the distal end of the elongated shaft a distance sufficientto provide the desired flexibility. A similar longitudinal slot 100 incombination with a radial slot 102 is depicted in FIG. 40. The radialslot extends radially from both sides of the longitudinal slot adistance sufficient to provide the desired flexibility. Anotherembodiment, as shown in FIG. 41, has a pair of longitudinal slots 100 onopposite sides of the elongated shaft. Both slots are at the sides ofthe cutting extension, and extend a sufficient distance to provide thedesired flexibility.

The cutting member 86 has cutting edges 88 on both sides as well as thefixed or hinged jaw member 42 or 40 having complementary edges 90 onboth sides so that rotation of the cutting member in either directionwill produce a cutting action. In the illustrated embodiment the cuttingmember is rotated by rotating the entire elongated shaft 22. Theelongated shaft is rotated using the cutting knob 38 or other mechanicalactuating means (See FIG. 5, button 108) located within the actuatingassembly 20.

As depicted in FIG. 2, while the jaw 26 is in the open position 54 theelongated shaft 22 and cutting member 86 are positioned proximal to thejaw. When the jaw 26 is in the closed position, the elongated shaft canbe advanced distally so that the cutting member extends over the jaw andany body vessel 50 grasped by the jaw, provided it is not already soconfigured. The cutting member can then be rotated in either directiondepending on which side the cut is desired.

The elongated shaft 22, which is integral with the cutting member 86,extends proximally to the actuating assembly 20 where it is fixedlyattached to a cutting knob 38 which extends generally perpendicular tothe shaft. The cutter knob is adapted to be manually controlled, andextends out of the barrel 34. The knob is seated within two slots in thebarrel. A longitudinal slot 104 extends distally through the barrel alength which is sufficient to advance and retract the cutting member 86from its fully extended position to its fully retracted position,approximately a half inch. A radial slot 106 extends in both directionsfrom the distal end of the horizontal slot. The slot extends asufficient distance around the barrel to rotate the cutting memberthrough a complete cut along the complementary cutting edge 90,approximately 90 degrees around the barrel in both directions. The slotsare wide enough to accept the cutting knob.

The embodiments of these features may vary without affecting theoperability of the invention. The cutting member 86 has been illustratedas integral with the elongated shaft 22. The cutting member may also bea separate structure located outside or within the elongated shaft. Theadvancing and rotating of the cutting member may be accomplished withsimilar mechanical and mechanical assisted means. Furthermore, thecomplementary cutting edges 90 may be on separate structure instead ofon the fixed jaw member 42 or on the hinged jaw 40.

The improvements of this instrument allow for an improved process ofligating and possibly cutting a body vessel. Using the invention withthe features identified, an operator grasps the handle 32 of theactuating assembly 20 and percutaneously inserts the manipulatingassembly 24 and elongated shaft 22 into the patient. The manipulatingassembly is then advanced to the body vessel 50 to be treated.

The body vessel 50 is positioned between the hinged jaw member 40 andthe fixed jaw member 42 while the jaw 26 is in the open position 54, andthe cutting member 86 is retracted. By squeezing the trigger 36 acertain distance the jaw is actuated into the closed position 56grasping and crimping the body vessel 50.

With the body vessel 50 grasped and crimped within the jaw 26 theoperator may then continue with the procedure either by ligating thebody vessel with an improved clip 28 or by cutting the body vessel. Theoperator may also choose to combine ligating and cutting the body vesselin different orders.

To ligate the vessel the operator may, for example, further squeeze thetrigger 36 so that an improved clip 28 is advanced over the body vessel50. With the body vessel ligated the operator releases the trigger to acertain position which loads another clip to be advanced. The operatormay then choose to cut the vessel or release the jaw and remove theinstrument from the body vessel.

To cut the vessel, either before, after, or without ligating the vessel,the operator may, for example, distally advance the cutting knob 38,which distally advances the cutting member 86 over the jaw 26 and thebody vessel 50. The operator may then choose to cut the body vessel oneither side, or both sides, of the jaw. To cut the body vessel on anyparticular side of the jaw the operator rotates the cutting knob throughthe radial slot 106 on the corresponding side of the barrel 34. With thebody vessel cut the operator returns the cutting member to the retractedposition by rotating the cutting knob back to the upright position andretracting it proximally within the horizontal slot 106 in the barrel.The operator may then choose to cut the vessel on the opposite side ofthe jaw, ligate the vessel with an improved clip 28, or release thevessel. Again, the preferred embodiment has the cutting member 86rotating over hinged jaw 40 to produce cutting action. Noproximal/distal translation of 86 is required for this embodiment.Rotating the cutting member 86 is all that is required to cut the vesselin this preferred embodiment.

The operator may release the body vessel 50, with or without cutting themember by, for example, releasing the trigger 36 which actuates the jaw26 into the open position 54. The operator may then either retract theinstrument from the patient or proceed to treat other portions of thesame or different body vessels. With this instrument the operator maycut an indefinite number of body vessels within an individual procedure.Furthermore, since the instrument contains a plurality of improved clips74 which are automatically loaded to ligate a vessel once another cliphas been used, the device may be used to ligate several vessels within asingle procedure.

The operator may choose to use this instrument in harvesting a bodyvessel 50. Body vessels are harvested for many reasons, includingtransplant and biopsy procedures. To harvest a body vessel the operatorfirst frees the selected body vessel by using this instrument to cut andligate the body vessel in multiple locations. Once the body vessel hasbeen freed from its connections to the body the operator grasps thevessel by squeezing the trigger 36 and actuating the jaw 26 into theclosed position 56 over the body vessel. Once the body vessel is firmlygrasped the operator withdraws the instrument and the vessel from thebody. The operator then released the trigger and actuates the jaw intothe open position 54, releasing the body vessel. Such a vessel is thenavailable for the procedures required.

As can be seen, the improvements of this method are the efficiency withwhich body vessels can be ligated and cut, as well as the flexibilitythe improved invention gives the operator in deciding how to continue inthe procedure. The efficiency in ligating body vessels is provided bythe improved grasping means of the jaw 26 and the improved ligatingmeans of the improved clip 28. The efficiency in cutting body vessels isprovided by the improved cutting means of the rotating cutting member86.

The instrument of the invention may be made from various materials suchas metals, preferably stainless steel, plastics, preferably apolycarbonate or polyetherimide resin, or the like. The instrument mayalso be made from a combination of materials. Usually if the instrument,or portions thereof, are made from stainless steel those portions willbe reusable after sterilizing. Those portions made from plasticmaterials will be disposable or reusable. The instrument may be designedto accept a replaceable storage tube of clips and this may beaccomplished with a reusable storage tube or a disposable one.

The improved clip 28 of the invention may be made from various knownmetals, for example, stainless steel, titanium, tantalum, super-elasticmemory metals or the like, or possibly from plastic materials that havesufficient resilience, such as poly olefins, glycolide-lactide polymersor similar plastics.

While the present invention has been described in terms of a simplemechanical device, there are multiple means which will achieve the samepurposes. An electric device with the same basic design may employelectric motors and other devices to perform the functions of theinvention, such as, actuating the jaw 26, advancing the clips 28,rotating the cutting member 86 and inserting and withdrawing theinstrument itself. One possible advantage of such an electric embodimentwould be the addition of computerized or electronic control of thefunctions. The same functions could also be accomplished using hydraulicor pneumatic means. With these embodiments the instrument would employpressurized fluids behind pistons to actuate the manipulating assembly24. Possible advantages of these embodiments would be greater forcesapplied and more precision accomplished in the procedure.

While the present invention has been described in terms of specificpreferred embodiments it will be readily apparent to those skilled inthe art that various modifications and alterations may be made withoutdeparting from the scope of the invention. Although this device has beenpresented as an endoscopic instrument it may also be used, with orwithout adaptation, in other types of surgical procedures. This devicehas been described in terms of performing procedures on body vessels,such as veins or arteries, however, those skilled in the art willrecognize that this device can be used on various body tissues.

What is claimed is:
 1. A clip for ligating tissue, comprising: a foldedunitary member having an open end, a close end, and an intermediatesection; said open end including diverging lip members, said lip membersbeing spreadable to receive tissue to be ligated; and said intermediatesection including an upper member, a lower member, and opposingretention surfaces on said upper and lower members, wherein saidintermediate section is twisted with respect to said open and closedends, wherein said upper member and said lower member are in the samevertical plane which is perpendicular to the opposing retentionsurfaces, wherein said upper member does not have an opening therein,wherein said upper member and said lower member do not have projectionsor sharp ridges on said opposing retention surfaces; and wherein saidupper member and said lower member have a compressive spring forceprovided by said closed end between said upper and lower members whenissue to be ligated is received between said opposing retentionsurfaces, said spring force being provided without the aid of a lockingmechanism to maintain sufficient compression on said tissue to stopblood flow within said tissue.
 2. The clip of claim 1, wherein saidopposing retention surfaces are in contact prior to application upon atissue to be ligated.
 3. The clip of claim 1, wherein there is a gapbetween at least a portion of said opposing retention surfaces prior toapplication of said clip upon tissue to be ligated.
 4. The clip of claim1, said opposing retention surfaces further comprising surface structurefor minimizing slippage.
 5. The clip of claim 1, wherein one of saidupper and lower members includes waves formed therein.
 6. A clip forligating tissue, comprising: a folded unitary member having an open end,a closed end, and an intermediate section; said open end includingdiverging lip members, said lip members being spreadable to receivetissue to be ligated; and said intermediate section including an uppermember, a lower member, and opposing retention surfaces on said upperand lower members, wherein said upper member and said lower member arein the same vertical plane which is perpendicular to the opposingretention surfaces, wherein said upper member does not have an openingtherein, wherein said upper member and said lower member do not haveprojections or sharp ridges on said opposing retention surfaces; whereinat least one of said opposing retention surfaces has a non-slip surfacecoating for minimizing slippage, and wherein said upper member and saidlower member have a compressive spring force provided by said closed endbetween said upper and lower members when tissue to be ligated isreceive between said opposing retention surfaces, said spring forcebeing provided without the aid of a locking mechanism to maintainsufficient compression on said tissue to stop blood flow within saidtissue.
 7. A clip for ligating tissue, comprising: a folded unitarymember having an open end, a closed end, and an intermediate section;said open end including diverging lip members, said lip members beingspreadable to receive tissue to be ligated; and said intermediatesection including an upper member, a lower member, and opposingretention surfaces on said upper and lower members, wherein said uppermember and said lower member are in the same vertical plane which isperpendicular to the opposing retention surfaces, wherein said uppermember does not have an opening therein, wherein said upper member andsaid lower member do not have projections or sharp ridges on saidopposing retention surfaces; wherein at least one of said opposingretention surfaces has a non-slip surface coating for minimizingslippage, said non-slip surface coating including silicon rubber, andwherein said upper member and said lower member have a compressivespring force provided by said closed end between said upper and lowermembers when issue to be ligated is received between said opposingretention surfaces, said spring force being provided without the aid ofa locking mechanism to maintain sufficient compression on said tissue tostop blood flow within said tissue.
 8. The clip of claim 7, wherein saidopposing retention surfaces are in contact prior to application upon atissue to be ligated.
 9. The clip of claim 7, wherein there is a gapbetween at least a portion of said opposing retention surfaces prior toapplication of said clip upon tissue to be ligated.
 10. The clip ofclaim 7, wherein said opposing retention surfaces further comprisingsurface structure for minimizing slippage.
 11. The clip of claim 7,wherein one of said upper and lower members includes waves formedtherein.
 12. A clip for ligating tissue, comprising: a folded unitarymember having an open end, a closed end, and an intermediate section;said open end including diverging lip members, said lip members beingspreadable to receive tissue to be ligated; and said intermediatesection including an upper member, a lower member, and opposingretention surfaces on said upper and lower members, wherein saidintermediate section is twisted with respect to said open and closedends, wherein said upper member and said lower member are in the samevertical plane which is perpendicular to the opposing retentionsurfaces, wherein said upper member does not have an opening therein,wherein said upper member and said lower member do not have projectionsor sharp ridges on said opposing retention surfaces; wherein at leastone of said opposing retention surfaces has a non-slip surface coatingfor minimizing slippage, and wherein said upper member and said lowermember have a compressive spring force provided by said closed endbetween said upper and lower members when issue to be ligated isreceived between said opposing retention surfaces, said spring forcebeing provided without the aid of a locking mechanism to maintainsufficient compression on said tissue to stop blood flow within saidtissue.
 13. The clip of claim 12, wherein said opposing retentionsurfaces are in contact prior to application upon a tissue to beligated.
 14. The clip of claim 12, wherein there is a gap between atleast a portion of said opposing retention surfaces prior to applicationof said clip upon tissue to be ligated.
 15. The clip of claim 12,wherein said opposing retention surfaces further comprising surfacestructure for minimizing slippage.
 16. The clip of claim 12, wherein oneof said upper and lower members includes waves formed therein.